PMA supplement
P980033 S050: VENOUS WALLSTENT
FDA PMA supplement · Panel Track · Boston Scientific Corporation
Key facts
| Original PMA | P980033 |
|---|---|
| Supplement number | S050 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VENOUS WALLSTENT |
| Generic name | Stent, iliac vein |
| Applicant | Boston Scientific Corporation |
| Product code | QAN |
| Received date | Sep 7, 2018 |
| Decision date | Mar 17, 2020 |
| Docket number | 20M-1115 |
| Notice date | Mar 18, 2020 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: